Serial Numbers: 020015;020021;020023; 020043;020051

Obstetrical and Gynecological Devices

2

No

Distributed in the states of CA, IL, NC, and NY.

Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators || during gynecological laproscopic procedures || Model: Ally UPS

Lot 153309

Obstetrical and Gynecological Devices

2

No

AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND

MILEX OMNIFLEX DIAPHRAGM SIZE 80 || Model: MXWF80

LOT 156966

Obstetrical and Gynecological Devices

2

No

US Nationwide Distribution in the states of: CA, FL, GA, HI, IL, KY, MD, MN, NC, NY, OH, TX, VT, and W A.

Milex Vaginal-Hymenal Silicone Dilators Set of 4 || P/N MX20 || Product Usage: || The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or rectal orifice

All lot numbers

Physical Medicine Devices

1

No

Worldwide Distribution - Nationwide Distribution and to the countries of : AUSTRALIA, BERMUDA, ECUADOR , FRANCE, NEW ZEALAND, SAUDI ARABIA and UNITED KINGDOM.

Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : || CooperSurgical || PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; || PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and || Fisher Brand. || PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; || PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX

Lot# 130438

Obstetrical and Gynecological Devices

2

No

US Distribution to the states of : OR and NY

Milex Arcing Diaphragm Size 95; Model Number: MXWS95

Lot No. 15420123 Expires Oct. 2016

Obstetrical and Gynecological Devices

2

No

Nationwide Distribution to CA, GA, and NY

Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 || SAGE In Vitro Fertilization, Inc. || A CooperSurgical Company || 95 Corporate Drive || Trumbull, CT 06611 USA

Lot no 16140184 expires April 2017 Lot no 15430149 expires Oct. 2016

Obstetrical and Gynecological Devices

2

No

Nationwide Distribution to CA, GA, and NY

Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium || Product Number: ART-8018 || Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).

Lot 14376100252004, Exp. Date 7/31/2020 (foil); 7/20/2031 (carton)

Ophthalmic Devices

2

No

US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.

clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses || The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.

Lot 14377101733005, Exp. Date 6/30/2020 (foil); 6/20/2030 (carton)

Ophthalmic Devices

2

No

US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.

clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses || The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.

Lot 14364100237018, Exp. Date 9/30/2020 (foil); 9/30/2022 (carton)

Ophthalmic Devices

2

No

US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.

56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses || The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.

Lot 14364100370010, Exp. Date 3/31/2020 (foil); 5/31/2020 (carton)

Ophthalmic Devices

2

No

US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.

56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses || The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.

Lot number 223333

Cardiovascular Devices

2

No

Worldwide Distribution - US Nationwide in the states of FL, GA, IN, NJ, and countries of Canada, Austria, Chile, Italy, Singapore

5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 || Product Usage: || The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of pneumoperitoneum. For uninhibited laparoscopic access, the Apple-Hunt Cannula/Trocar provides greater instrument maneuverability while maintaining an airtight seal -with no bulky external valves, fittings, or housings. The ergonomic trocar design is simple to use and features a smooth cannula/trocar transition for easier sleeve insertion and reduced risk of patient injury.

Lot number: 212074

Obstetrical and Gynecological Devices

2

No

CA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain

Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151

Product Code: FASDL1 6G, DL 16035111, DL 16035141, DL 16035641 Affected Lot Numbers: 0911FAS DL16G01, 1211FASDL16G01, 0212FASDL16G01, 0412FASDL16G01, 0512FASDL16G01, 0712FASDL16G01, 1212FASDL16G01, 0113DL1603511101, 0213DL1603511101, 0213DL1603511102, 0313DL1603511101, 0413DL1603511101, 1112DL1603514101, 0313DL1603514101, 0213DL1603564101, 0513DL1603564101

Needle, aspirating oocyte, single use

Part number: 7-72-1145/20 Product description: 145μm EZ-Strip LOT number: 150299-01 Expiry date: June 2018 (2018-06)

Single-Use Denudation and Handling System

16280126 Quinn's Advantage Medium with HEPES

Batch Recovery of Oocyte Double Ocular Oocyte Needles